Recall Z-2093-2021 ยท JQP Calculator/Data Processing Module, For Clinical Use
Soft Computer Consultants, Inc.
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.
| Date | Mar 31, 2021 |
| Status | Terminated |
| Reason | Software showing wrong results reported, PDF not match HIS. |
| Root cause | Software Design Change |
| Action | The firm sent an " URGENT: MEDICAL DEVICE RECALL" letter dated 6/2/2021 to its sole consignee of the correction on 06/02/2021 by mail. The letter described the product, problem and actions to be taken. The consignee was instructed to do the following: Acknowledge receipt of this letter in the TMS task Give permission to load Hot Fix on Test environment Perform validation activities to completion Acknowledge Hot Fix has been moved to Live environment and is working as expected Type of action by Company: All clients on affected lines of software have been notified of the recall. SCC will pro |
| Quantity | 1 |
| Distribution | US Distribution to: CA only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.